Rulemaking History for OTC Exocrine Pancreatic Insufficiency Drug Products
Final Monographs (21 CFR 310.543):
Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency
OTC Exocrine Pancreatic Insufficiency Drug Products found on this page:
Exocrine Pancreatic Insufficiency Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 12/21/1979 | 44FR75666 |
| Correction | 3/25/1980 | 45FR19266 |
| Extension of Comment Period | 3/25/1980 | 45FR19265 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph Pancreatin and pancrelipase are GRASE | 11/8/1985 | 50FR46594 |
| Correction | 12/2/1985 | 50FR49409 |
| Proposed Rule: Withdraws tentative final monograph; No GRASE active ingredients | 7/15/1991 | 56FR32282 |
| Notice: Public workshop to discuss testing (needed for NDAs) | 3/11/1992 | 57FR8586 |
| Final Rule | Date | FR Citation |
| Final Rule: No GRASE active ingredients | 4/24/1995 | 60FR20162 |
| Notice: Availability of guidance on submitting an NDA | 4/28/2004 | 69FR23414 |
Exocrine Pancreatic Insufficiency Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 5/16/1990 | 55FR20434 |
| Correction | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 11/7/1990 | 55FR46914 |
| Correction | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name | 1/30/1992 | 57FR3526 |